osseointegration: a rehabilitation perspective · 2003-12-16 · osseointegration •history –...

Joseph M. Czerniecki, MD, Associate Director, VA Center of Excellence

Professor, Department of Rehabilitation Medicine, University of Washington

Osseointegration: a Rehabilitation Perspective

Setting the Stage

General Model of Functional Recovery after Illness or Injury

Func

tion a

l Sta

tus

Time

Onset of Injury

Onset of Recovery

Maximal FunctionalRestoration

Function Across the Lifespan

• Minimize the functional decline associated with illness or injury.

• Prevent additional disability during the acute care episode.

• Shorten the time course of recovery.

• Increase the ultimate functional outcome.

• Preserve the functional status across the lifespan of the individual.

The Goal of Rehabilitation is the Enhancement and Preservation of Function.

Prevention of the Need for AmputationFu

nctio

nal S

tatu

s

Time

Onset of Injury

• Continued research on the development of predictive limb injury scales that not only predict salvage but the extent to which salvage will lead a more functional limb than amputation

Prevention of Need for Amputation

Amputation Decision MakingFu

nctio

nal S

tatu

s

Time

Onset of Injury

Decision to Amputate

Amputation Level Decision Making; Its Effect on Functional Outcome

• What is the optimum level of amputation?

• When is the outcome of a compromised transtibial residual limb better than a transfemoral amputation?

The Compromised Transtibial Residual Limb

Early Post Amputation RehabilitationFu

nctio

nal S

tatu

s

Time

Onset of Injury

Decision to Amputate

Onset of Recovery

Early Post Amputation Rehabilitation• Prevent Complications

– Joint Contracture– Disuse atrophy– CV deconditioning– DVT

• Wound Management• Pain management -Phantom Limb Pain• Psychological adaptation• Discharge destination

– Rehab Inpatient stay– Home with OP Rehab

Prosthetic FittingFu

nctio

nal S

tatu

s

Time

Onset of Injury

Decision to AmputateProsthetic Fitting

Onset of Recovery

Prosthetic Innovations and Developmentsto Reduce Primary Disability

Impact Absorbing Pylons

Prosthetic Feet

Centralprocessing

unitA/D

Power Source[Li-Ion Battery]

Knee angle

Ankle moment

Battery State

Valveprocessor

Motor

Valve

Angle sensor

Adaptive “Intelligent” Knees

Prevention of Secondary DisabilityFu

nctio

nal S

tatu

s

Time

Onset of Injury

Decision to AmputateProsthetic Fitting?

Secondary Disability

Onset of Recovery


• Low Back Pain– Incidence 52% (Ehde et al. 1999), 76% (Smith et al. 1999).

• 50% mod to severely bothersome (Ehde et al. 1999)

• Knee Degenerative Arthritis– 63% TF, 41% TT, 21% Control (Hungerford and Cockin

1975)

• Knee Pain3 times increased risk in TF, 2 times increased risk in intact limb TT amputees, 5 times less relative risk in prosthetic limbs of TT

amputees ( Norvell et al 2003)

Prevention of Secondary Disability

• Very early stage in understanding what the contributing factors are.

• Recent information suggests that choices of prosthetic components and optimizing prosthetic alignment may influence loading of the intact extremity.

Maximizing Functional Outcomes Fu

nctio

nal S

tatu

s

Time

Onset of Injury

Decision to AmputateProsthetic Fitting


Onset of Recovery

Osseointegration

Tissue Loading in Amputation

• Loads to Residual limb– Body weight– Moments of force to stabilize

and produce movement

• Decreased Length Increased Tissue loads

QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.

Current Prosthetic Technology

• Soft Tissue / prosthetic socket interface

• Socket designs

• Interface materials



Interface/Suspension Systems



Sources of Functional Limitation

• Legro et al. 1999 amputee rating of importance– Comfort – Avoidance of mechanical skin injury– Enhancement of ability to ambulate

• Kegel 1980 factors that limit sports participation– Discomfort and mechanical skin injury– Fatigue and reduced endurance– Inability to walk distances and to run

Patient Perceptions - a Qualitative Approach

Residual Limb Pain and Functional Limitation

• 78 consecutive amputee patients admitted to a US urban trauma center, 85% motor vehicle related.

• 43% satisfied with prostheses comfort.• 25% very/extremely bothered with mechanical skin

injury.• 25% very/extremely bothered by perspiration and

heat• Dillingham et al. 2000 Am J Phys Med Rehabil

Traumatic amputees/ mixed levels of amputation.

• 35% rated residual limb pain as severe.• Smith et al. Clin Orthop 1999

• 38% rated residual limb pain 7/10 or greater.• 33% rated residual limb pain as severely

bothersome.• Ehde et al. Arch Phys Med Rehabil 2000

Mixed amputation levels and etiologies.


• 62% report being somewhat or completely satisfied with their health.

• And only 6% reported being dissatisfied with their lives.

• The Mental component summary of the SF-36 is the same as age and sex matched controls.– in spite of significant reductions in physical role functioning

and pain on the SF-36.

– Dillingham et al 2000 and Pezzin et al 2000


Osseointegration

• History– Acknowledge Douglas Smith, MD– VA funded animal research since early 1960’s

• Vitallium, ceramic, carbon implants• Other materials to bridge the soft tissue gap.

• “the animal managed exceedingly well. A freak accident broke the Vitallium rod when the animal jumped a drainage ditch. He was, at the time, being pursued by the principal investigator who was attempting to rope the goat in order to inspect the leg. During this rodeo performance, the animal was leading the herd by several lengths, which proves the function of the artificial limb. Hall WC, Bulletin of Prosthetics Research 1973

• Phase I• Surgical revision of

muscular attachments • Insertion of implant• Most do not wear a

prosthesis during this time.

Osseointegration; Phase I SurgeryInsertion of Titanium Implant

• 6 months after Phase I• Surgical revision of

residual limb with insertion of abutment.

Osseointegration; Stage II surgery Revision with Insertion of Abutment

• Limb loading• Begins 8wks after Stage II

surgery.• Add 10 kg/wk• Approx 3 mo. to achieve

loading to full body weight.• Muscle strength,ROM

program.• Pain as an issue in relation to

limb loading

Osseointegration; Progressive Limb Loading

• Progressive weight bearing and ambulation for 3 mo. in parallel bars.

• Followed by progressive ambulation with crutches and canes for additional 3 mo.

• Conventional components – Require 140 deg knee flex– Torque absorber– Fail safe component

Osseointegration; Progressive Prosthetic Weight Bearing

OsseointegrationFu

nctio

nal S

tatu

s

Time

Onset of InjuryDecision to Amputate

Prosthetic Fitting

Onset of Recovery

Osseointegration

?

18 mo

Osseointegration; Data

• Program Started in 1997 (Experimental Program)– 11 patients selected from 56– No patients with Diabetes or Vascular disease or immune deficient– Primary indication“Failure of conventional prosthetic fitting”.

• skin soft tissue problems– Adults less than 70 years of age.– Medical status will allow two surgical procedures.

• Time – 18 mo. time investment from start to full weight bearing – On average 46 outpatient visits after stage II surgery.– Need for relative geographic proximity (150 miles?) to

amputation/rehabilitation care.

Sullivan et al. Roehampton experience..Prosth Orth Int. 2003

Osseointegration; Outcomes

• 3 patients with osteomyelitis (28%) – 2 had implant removed,

• (two additional surgeries), gentamycin impregnated cement insertion and removal.

• No shortening of residual limb, one returned to prosthetic use.– 1 on chronic antibiotics

• Psychosocial consequences– 4 divorces in 11 subjects.

• No improvement in gait (descriptive)

• No other measures of function, mobility, quality of life.

• Activity limitations– Swimming; infection risk?– Limitations in running, jumping, heavy manual work; risk of

mechanical failure.– Cosmetic limitations, no cover above the prosthetic knee.


• Enthusiastic expression of appreciation. – “like the blind being able to see?”

• Enhanced Comfort

• Perceived improved proprioception.• Perceived reduced energy cost during

ambulation.


In successful candidates (no objective measures)

Osseointegration:Is it currently a clinical strategy that is

ready to be used on Veterans orCombat related amputees?

• In some countries it is an accepted clinical procedure.

• In some countries it is considered an experimental procedure? (Canada, Australia, England)

• Who? When do benefits outweigh risks?• Roehampton

– Only those that are a failure of conventional prosthetic management. Skin soft tissue problems.

– No vascular disease, diabetes, or medical conditions that would increase risk of infection, or medical disease that would pose undue surgical risk.

– Less than 70 years of age, less than 100 kg• What outcome measures? Control population?• Multi-center?

Osseointegration:A Clinical procedure vs Experimental procedure

Informed Consent

• Moving away from the concept of legalistic protection of physician and hospital.

“Reasonable people need to know their treatment options, the general risks, benefits, and probable outcomes of each option, and the reasons that the physician has recommended a specific treatment.”

Informed Consent: James Bernat, Muscle and Nerve, 2001

Challenges of Osseointegration

Skin - Implant InterfaceBone - Implant Interface

Three Piece Implant Modeled after Dental Implant Design

Creation of Sub-DermalSkin/Bone Interface

Challenges of Osseointegration; the Bone-Implant Interface

• Key limitation is time– 6 months to begin wt

bearing.– Additional time for

progressive weight bearing.

– Rehabilitation delay– Remove patients from

their typical social/physical roles.

• Is it possible to accelerate the loading without adverse effect?

• Is it possible to insert the implant as part of the primary amputation. – ? Limit the adverse impact on rehabilitation time– Is there a difference to time of osseointegration

if there is normal cancellous bone or osteopenic bone?

Challenges of Osseointegration; the Bone-Implant Interface

Challenges of Osseointegration;the Skin Implant Interface

• Infection– Serious Adverse Outcome– ? Novel biomaterials

approach to reduce risk of infection.

Summary

• Dilemma– Intervention is not trivial and is costly– Published outcomes are limited in quality and number– Significant side effects– BUT……in those that are successful patient response

is very impressive. • Clinical utility?• Experimental procedure? • Basic science research on bone implant and skin

implant interface.

Can we do better?

Event Class TimeMen's 100 m A2 12:86

A4 11:33Men's 200 m A2 27:39

A4 22.85Men's 1500 m A 4 5:50.88

osseointegration: a rehabilitation perspective · 2003-12-16 · osseointegration •history –...

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